The present invention relates to a method and apparatus for the univocal and permanent connection of containers for medial use to a given patient.
In a clinical investigation process it is possible to distinguish between a pre-analytical step, an analytical step and a post-analytical step.
The pre-analytical step is the step which precedes the analysis and is constituted by the processing of the prescription made by the `base doctor` or by the `specialist doctor` (with all the flow of related data among the different bodies which have a say in the matter, from the administrative bodies to the technical ones, to end with the party directly affected), by the taking of the sample, by its identification, by the subsequent handling towards and within the laboratory's operational centres, by the corresponding handling operations (other than the analytical ones).
The analytical step is the step in which the material is analysed in its components and the post-analytical step is the step in which the results of the analyses are collected and printed in a final report which is handed to the patient and/or to the doctor.
The strong growth in demand for laboratory work over the past twenty years has involved great technological development with the creation of a wide area of laboratory automation: in particular the analytical step and the post-analytical step have been automated, while scant attention has been paid to the automation of the pre-analytical step.
In current laboratory medicine the processing of raw materials constituted by biological materials (blood, urine, etc.) taken from the same patient, as well as their communication, occurs manually or, under the best of circumstances, semi-automatically and in any case, at all times, with serious prejudice to the correct attribution of the analytical result.
In the case of manual processing the doctor or the nurse who takes the sample manually writes the patient's name (and possibly the requested analyses) on the test tube in which the biological material (blood, urine, etc.) is collected, and on the request for analyses.
Generally speaking, when they enter the laboratory, a number is written on the test tubes belonging to each single patient and on the request for analyses, commonly known as the access number, which, under the best of circumstances, is repeated each time there is a transfer of biological material from the original test tube to other subsidiary test tubes; thus number out to constitute the safety element for the identification of the material along the entire process. In certain cases the access number is then replaced with another number, different from one type of analysis to the next, or from one laboratory section to the other.
The name of the patient is obtained at the time the sample is taken by asking the patient himself (if he is conscious) or by taking it from the bed in which the patient is or from the clinical record (when the patient is unconscious).
The risks of error connected with these operations are obvious: possibility of error in the manual writing on a test tube and/or a request for analysis on the part of a tire operator who, perhaps, has spoken with two patients in succession; possibility of exchanging data from one patient's clinical record and another's name; possibility of exchanging test tubes and/or medical reports related to different patients. In addition, error is intrinsic in the abovementioned methodology since the systematic exchange of technology and code number, in the different operations of identification of the different steps constituting the analytical process, systematically creates such a possiblity.
In the case of semi-automatic operations, when the patient is admitted, to hospitals or other health organizations equipped with a computer, a certain number of labels is produced containing the name and address of the patient, which are inserted in his clinical record. When it is necessary to execute laboratory analyses, the section staff takes one or more labels, adds the necessary data (say, the analyses requested at that time, the date, etc.) and manually sticks them on to the test tubes into which the biological material will be inserted. As an alternative, labels are produced by the computer when it is necessary to execute laboratory analyses.
It is obvious that, in these cases, such information cannot be ready by machines.
Progress over this system has been attained during the past few years by providing the patient, at admittance, with an identification card with a bar code. Such identification card, generally located in the clinical record or at the patient's bed, or contained in an armlet which cannot be removed from the patient, is read by a suitable reader which transmits the information to a bar code printer capable of duplicating it on adhesive labels, subsequently stuck manually both on to the preprinted forms of requests for analyses and on to the test tubes which will contain the patient's biological materials.
In the laboratory there is in this case available on each test tube and/or corresponding request for analyses information readable by man and/or information readable by means of a suitable device capable of identifying the patient and if necessary the analyses to be executed in an indirect and non-univocal form over time.
Such a semi-automatic identification system, even though it does represent an improvement with respect to the manual system, has some limits.
The paper support requires an adequate size for the test tube, it requires case in handling the test tube and, in addition, the glue with which it adheres to the test tube can penetrate, due to the permeability of the wall, into the test tube thus contaminating its contents.
If the solution with the bar code is adopted, which today represents the most advanced technology, it is also necessary to consider that the space utilized with this type of memorisation is comparatively large so that on the label of an ordinary test tube only one code can be stored with which to access the complete series of the patient's data stored, say, in the central computer, in the peripheral computer or in the clinical record.
Lastly, the operation of manually reading from the test tube or from the armlet can it itself be a source of human error.
All these processes in any case involve a non-obligatory temporal continuity between the time the sample is taken and the preparation of the test tube, so that there is always the risk of exchanging test tubes between two patients.